Benign uterine leiomyomas (fibroids) are the most common pelvic tumor in women (estimated lifetime risk of 70 percent in white women and 80 percent in black women) (Buttram, V. C., Jr. and R. C. Reiter, Fertil Steril, 36(4): 433-445 (1981); Serden, S. P. and P. G. Brooks, J Reprod Med, 36(10): 697-699 (1991); Baird, D. et al., Am J Obstet Gynecol, 188(1):100-107 (2003)). Uterine sarcoma is rare (3 to 7 per 100,000 in the United States population) with a poor prognosis (Brooks, S. E., et al., Gynecol Oncol 93(1): 204-208 (2004)). It is well recognized that cancer is an enormous global health problem. The American Cancer Society estimates that in 2008 alone there were an estimated 12.7 million new diagnoses of cancer and 7.6 million deaths caused by cancer Reynolds, P. N., et al., Nat Biotech, 19(9): 838-842 (2001)). The time at which a cancer is detected, both at initial cancer diagnosis and during tumor recurrence, is one of the most important prognostic factors that substantially affect patient outcome, because if cancer is detected early, current treatments are likely to be more effective (Etzioni, R., et al., Nat Rev Cancer, 3(4): 243-252 (2003)).
Unfortunately, the majority of cancers are detected relatively late, leading to high mortality rates. These rates are expected to double by 2030 unless more effective detection strategies and treatments are developed. To stem the tremendous loss of life caused by this terrible disease, a broadly applicable tool capable of detecting cancers in their earliest stages is urgently needed. Proper differentiation between benign and malignant uterine lesions can dramatically improve the efficacy of patient treatment modalities. However, despite marvelous progress in cancer specific blood-based biomarkers, many of such biomarkers have failed clinically because of presence of limitations such as highly variable background expression from nonmalignant tissues and tumor heterogeneity.
Therefore, it is an object of the invention to provide compositions and methods for the early detection of cancer, in particular uterine cancer.
It is another object of the invention to provide compositions and methods for the treatment of cancer, in particular uterine cancer.